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What is Biomedical What is Biomedical Ethics?Ethics?Philosophical study of ethical
controversies brought about by advances in biology and medicine
Relationship among ◦life sciences◦biotechnology◦medicine◦politics◦ law – discussion today ◦philosophy
Biomedical Ethics Biomedical Ethics – A Few Legal Areas– A Few Legal Areas
Today’s topics◦Confidentiality◦HIPAA◦Compliance◦Informed Consent◦Whistleblowers
Takeaway PointsTakeaway PointsUse common sense
Go with your gut — do the right thing
Ask the experts
If you proceed, how would it appear on the front page of the newspaper?
Could you defend the benefits vs. the risks in a way a non-clinician / non-researcher could understand?
Biomedical Ethical Issues Biomedical Ethical Issues – Numerous and Complex – Numerous and Complex
Don’t try to know all the applicable rules/regulations/laws on the topics of confidentiality, compliance, HIPAA, informed consents, etc. – leave it to the lawyers. USF also relies on expert outside counsel
With bioethical issues, not always a matter of what one can or cannot do — it’s often a matter of weighing the risks vs. benefits
Confidentiality in the Confidentiality in the University WorldUniversity WorldHIPAA applies to covered entities (more
later)Florida state law on medical privacy is
more restrictive than HIPAA◦ Which is allowable
Student records protected from disclosure under FERPA — also applies to Residents
Generally, all written records of faculty or staff of this University can be released to the public◦ Exemption from disclosure examples:
Social Security Numbers Medical information Research protocols Impaired practitioner information
Florida Laws on Medical Florida Laws on Medical RecordsRecordsMedical records are confidential
Some records are “Super” confidential◦Mental health◦Substance abuse◦STDs◦Genetic testing◦HIV
Health Insurance Portability Health Insurance Portability and Accountability Act of and Accountability Act of 1996 - HIPAA1996 - HIPAAGoal
◦To protect patient privacy, Protected Health Information (PHI) and allow portability of health insurance.
◦Covers privacy, security (use of technology)
◦Broad congressional attempt at healthcare reform
HIPAAHIPAAPurpose is to increase efficiency
and effectiveness of health care system through
◦Electronic exchange of information
◦Standardization of that information
◦Enhanced security and privacy of Protected Health Information (PHI)
HIPAA HIPAA Perceived need – 1 in 6 patients omit medical
history information from physician out of fear of misuse or mishandling
Applies to covered entities, health plans, HMOs, Medicare, providers, health clearinghouses.
USF is a “hybrid” covered entity. USF College of Medicine, College of Nursing, Student Health Services, Byrd Institute are covered because they are entities providing medical treatment for which they electronically bill.
Covered entities must:◦ Maintain reasonable & appropriate safeguards◦ Maintain physical safeguards
HIPAA Privacy RuleHIPAA Privacy RuleKey Features PHI Uses and disclosures Consents Authorization Notice of privacy practices Minimum necessary information given Patient rights Business associates Marketing, fundraising and research Interaction with state privacy and confidentiality
laws Penalties
HIPAA AcronymsHIPAA AcronymsPHI
Protected Health Information - Health and demographic information about an individual
IIHIIndividually Identifiable Health Information, e.g., name, address, dates, telephone number, SSN, medical record #, fingerprints, photographic images, etc.
Permitted Use of PHI / IIHI Permitted Use of PHI / IIHI ––“TPO” “TPO” Subject to a general consent from
the patient, HIPAA permits use or disclosure within the covered entity or to a business associate for◦Treatment◦Payment◦Health Care Operations, which can
include Qualify assessment and improvement Peer review/credentialing Medical review, legal services, auditing Business planning and development Administrative activities
HIPAA RequirementsHIPAA RequirementsProviders must obtain prior consent to
treatment, except ◦In emergencies, or◦Where provider is obligated by law to
provide care◦Providers can condition treatment on
granting of consent to treatment
Authorization must be obtained for all uses and disclosures other than TPO or those mandated by law
Provider must give privacy notice to patients
HIPAA - Other HIPAA - Other Applicability Applicability Business Associate
Person or entity who provides services on behalf of covered entity or to a covered entity and is not a member of your workforce
ResearchIf it involves health information about living participants, deceased persons, is related to human tissue samples, chart review and or stored in databases or repositories
Individual Rights Under Individual Rights Under HIPAAHIPAAReceive written notice of privacy
practices
Request restrictions on uses and disclosures
Access, inspect and copy their PHI
Request amendment or correction of the PHI
Receive an accounting of disclosures of their PHI (except those related to treatment, payment and operations)
Enforcement of HIPAA Enforcement of HIPAA — as to state agencies — as to state agencies
Enforcement◦DHHS/OIG◦CMS◦DOJ◦State Attorneys General
Penalties for the intent to sell or use PHI◦Civil and criminal penalties with fines
up to $250,000, and/or◦10 years in prison
Amendments to HIPAA – Amendments to HIPAA – HITECH HITECH HITECH – Health Information
Technology for Economic and Clinical Health◦Part of the American Recovery and
Reinvestment Act (ARRA) of 2009 – eff. 2/17/09
◦Expanded definition of privacy breaches◦Greater reporting/notification of suspected
breaches◦Responsibility to investigate breaches and
mitigate losses enhanced◦ Improved enforcement
ComplianceComplianceJust do itSomeone else’s alleged non-compliance
does not grant permission to others to do the same
Hundreds of laws/regulations USF employees have to comply with in medical/research areas
Different types of conflict of interest considerations◦ Sponsored research
◦ As a public officer/employee
◦ University employment/conflict of commitment, institutional COI
WhistleblowersWhistleblowersFederal and State False Claims Act
(FCA)— see class handout
Federal FCA ◦Old law◦Very broadly defined◦Whistleblower protections◦Penalties steep – civil penalty for each
claim◦Multi-million dollar payouts, even for public
entities, e.g., UMDNJ – over $350M
Other “Whistleblower” Other “Whistleblower” ProvisionsProvisions
Other state laws on subject
General state law on whistleblowers
– not just in medical arena◦Usually applied in employment-related
context
Important principle for USF – if complaint is made, no retaliation allowed
Informed ConsentInformed ConsentConsents & authorization requirements
◦ Written in plain language◦ Inform patient of the procedure’s risks/benefits◦ How will it be used◦ Signed and dated
Divorced parents◦ Either parent can consent to medical or
surgical treatment unless court order provides otherwise
◦ Physical custody does not determine authority to consent
◦ If divorced parents disagree, consent of either parent will suffice
Non-parents can consent under certain circumstances
Minor’s RightsMinor’s RightsMinors can give consent in certain
situations◦Emancipated◦Married minor◦Pregnant minor◦Minor mother
Minors can consent for treatment of◦STDs◦Maternal health/contraception◦Substance abuse◦Outpatient emotional crisis counseling
Valid AuthorizationsValid AuthorizationsAuthorizations must be obtained for
all uses other than TPO or those mandated under law and must include:◦Description of the information to be
disclosed◦Name of person or entities to whom the
information will be disclosed◦An expiration date◦ Information regarding right to revoke◦Date and signature
Consent PrinciplesConsent Principles
Remember…Have consents drafted and reviewed
by counsel with input from providers
Inform patient what is happening and what might happen
Verify they understand scope of the consent
Discuss consent in person
Don’t rely exclusively on a consent to insure no legal action will be brought